9 October 2024 US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company.
Nanoscope Therapeutics says that, following a productive FDA meeting with the US Food and Drug Administration (FDA) for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP), the company will commence with submission of a Biologics License Application (BLA) in the first quarter of 2025. 10 October 2024
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
China’s Quantum Pharmaceuticals has announced a significant licensing agreement between its biologics-focused subsidiary, Ailux Biologics, and Johnson & Johnson. 10 October 2024
USA-based Kezar Life Sciences announced this week that it was pausing its Phase IIb PALIZADE trial evaluating zetomipzomib in lupus nephritis (LN) following the deaths of four patients. 10 October 2024
Advances in gene editing, such as the FDA approval of Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) in December 2023 for the treatment of beta thalassemia and sickle cell disease, have fueled significant interest in innovative epigenetic drugs. 10 October 2024
Gene therapy start-up GEMMA Biotherapeutics (GEMMABio) has announced a significant partnership with Brazil's Fiocruz, a key supplier for the Brazilian Ministry of Health. 10 October 2024
California’s Arda Therapeutics, a biotech focused on targeted cell depletion therapies for chronic diseases, has announced the successful completion of a $43 million Series A financing round. 9 October 2024
Purespring Therapeutics, a gene therapy company focused on transforming the treatment of kidney diseases, has raised £80 million ($105 million) in a Series B financing. 9 October 2024
German family-owned pharma major Boehringer Ingelheim and USA-based Circle Pharma (have entered into a research collaboration and license agreement with the shared goal to develop a first-in-class cyclin inhibitor that can halt the growth of cancer cells potentially offering hope to those living with hard-to-treat cancers. 9 October 2024
Calluna Pharma, a biotech focused on treating inflammatory and fibrotic diseases, has appointed Mark Gaffney as its new chief executive. 9 October 2024
Cambridge, USA-based City Therapeutics has announced its launch with a vision to lead the future of RNA interference (RNAi)-based medicine. 9 October 2024
Zephyrm Bioscience, a Cayman Islands-based biotech, has filed for an initial public offering (IPO) in Hong Kong, seeking to raise additional capital to advance its cell therapy pipeline. 9 October 2024
Privately-held UK biotech Curve Therapeutics has announced the appointment of Rab Prinjha as chief research and development (R&D) officer. 9 October 2024
UK-based AviadoBio, a LifeArc Ventures portfolio company, and Astellas Pharma today announced an exclusive option and license agreement for AVB-101. 8 October 2024
China-headquartered clinical-stage biotech MediLink Therapeutics has announced a global clinical trial collaboration and supply agreement with US major Amgen. 8 October 2024
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. 21 December 2020
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
Swiss pharma giant Roche has announced positive top-line results from two identically designed global Phase III studies, testing the novel biologic faricimab. 21 December 2020
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
Shares of UK-based rare diseases specialist Mereo BioPharma (Nasdaq: MREO) shot up almost 63% to $3.60 on Friday, after it announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). 19 December 2020
Janux Therapeutics has announced a strategic collaboration with Merck & Co valued at more than $1 billion to develop novel T cell engager (TRACTr) immunotherapies for the treatment of cancer. 18 December 2020
Any doubts that Moderna’s (Nasdaq: MRNA) COVID-19 vaccine is moving swiftly closer to patients in the USA and European Union (EU) have all but vanished this week. 18 December 2020
Privately-held US biopharma firm Cadent Therapeutics has reached a definitive agreement with Novartis, under which the latter will acquire all of the outstanding capital stock of Cadent, and marking the third M&A deal for the Swiss pharma giant this year. 18 December 2020
Coronavirus vaccine co-developer Pfizer has refuted suggestions that there is any delay to its manufacturing and distribution schedule. 18 December 2020
GlaxoSmithKline today said it will co-lead a Series A investment in Adrestia Therapeutics, a UK-based biotechnology company using cutting edge molecular biology to develop precision medicines. 18 December 2020
The US Food and Drug Administration has approved Benlysta (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. 18 December 2020
The Institute for Clinical and Economic Review (ICER) has published its final recommendations on two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 17 December 2020
There are eight mRNA COVID-19 vaccine candidates currently in Phase II or Phase III clinical trials. These vaccines are faster to develop than traditional vaccine formulations, as they use only the genetic sequence of the virus. 17 December 2020
MacroGenics has won US Food and Drug Administration approval for its HER2-targeting biologic Margenza (margetuximab-cmkb) in breast cancer. 17 December 2020
The chief scientific adviser to the US government’s Operation Warp Speed program has said that only 5% to 20% of the roughly 65,000 doses of COVID-19 antibody treatments shipped to states around the country every week end up going to patients. 17 December 2020
US biotech Novavax has announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, the company’s candidate vaccine against COVID-19. 17 December 2020
French biotech firm AB Science yesterday announced that the Phase IIb/III study (AB09004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint. 17 December 2020
Irish biotech ONK Therapeutics has inked three new exclusive option agreements, boosting its off-the-shelf natural killer (NK) cell therapy platform. 17 December 2020